BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP IN STYLE ADVANCED - ON-THE-GO TOTE

    MDR report key: 5739255 · Received June 21, 2016

    Report

    Report Number
    1419937-2016-00154
    Event Type
    Malfunction
    Date Received
    June 21, 2016
    Date of Event
    May 23, 2016
    Report Date
    May 23, 2016
    Manufacturer
    MEDELA INC
    Product Code
    HGX
    PMA / PMN Number
    K031614
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER WAS SENT A REPLACEMENT TRANSFORMER. THE PRODUCT WAS RECEIVED ON 6/9/2016. THOUGH THE PRODUCT HAS BEEN RECEIVED, IT HAS NOT YET BEEN TESTED/ANALYZED BY QUALITY ENGINEERING. THEREFORE, NO CONCLUSIONS CAN BE MADE AS TO THE CAUSE OF THE EVENT. HOWEVER, THE CUSTOMER REPORTED SEEING A SPARK FROM THE EXPOSED WIRES ON HER 920710 (PRIOR TO REV L) TRANSFORMER, WHICH IS A SAFETY RISK. AS A RESULT OF CAPA (B)(4) WHICH WAS INITIATED FOR PUMP IN STYLE TRANSFORMER OVERHEATING/MELTING ISSUES, A FIELD ACTION SAFETY NOTIFICATION WAS INITIATED ON 04/04/2011. ACTIVITIES RELATED TO THIS NOTIFICATION ARE ON-GOING.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO MEDELA CUSTOMER SERVICE ON 5/23/2016, THAT THE CORD ON HER PUMP IN STYLE ADVANCED-ON-THE-GO-TOTE BREAST PUMP ADAPTER IS FRAYED AND THE WIRES EXPOSED. THE CUSTOMER REPORTED SEEING A SPARK FROM THE EXPOSED WIRES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    394561 PUMP IN STYLE ADVANCED - ON-THE-GO TOTE PUMP, BREAST, POWERED HGX MEDELA INC 57063/9207010 131/PRIOR TO REV L

    Patients

    Seq Age Sex Outcome Treatment
    1